Core Insights - Cue Biopharma, Inc. has reported promising results from its Phase 1 trial of CUE-101, showing an overall response rate (ORR) of 50% in treatment-naïve patients with recurrent metastatic HPV+ head and neck squamous cell carcinoma (HNSCC) [3] - The 12-month overall survival (OS) rate is 88%, indicating a significant reduction in the risk of death compared to historical data [3] - The median overall survival (mOS) is currently estimated at 32 months [3] Company Overview - Cue Biopharma is a clinical-stage biopharmaceutical company focused on developing a novel class of therapeutic biologics aimed at selectively engaging and modulating disease-specific T cells for treating autoimmune diseases and cancer [2][7] - The company's proprietary platform, Immuno-STAT™, is designed to harness the body's immune system without the adverse effects associated with broad systemic immune modulation [7] Product Details - CUE-101 is the most advanced clinical stage drug candidate from the CUE-100 series, designed to activate and expand HPV16 tumor-specific T cells [6] - The mechanism of action involves presenting two signals to T cells: one from the HPV E7 protein and another from an engineered IL-2 variant [6] - The CUE-100 series consists of Fc-fusion biologics that selectively target and activate tumor-specific T cells while minimizing systemic activation and potential toxicities [5] Clinical Trial Insights - The Phase 1 trial of CUE-101 is fully enrolled and evaluates the drug as a monotherapy and in combination with pembrolizumab (KEYTRUDA) for HPV16+ driven recurrent/metastatic HNSCC [6] - The trial results indicate that CUE-101 may represent a breakthrough therapeutic approach for patients battling HNSCC, as stated by the company's chief medical officer [4]